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New Regulations on Medical Device Studies


When a medical device has not been approved for marketing in the U.S. or has been approved but is still undergoing clinical evaluation, it is referred to as an investigational device. Investigational devices not yet approved for marketing can be permitted for use in clinical studies by receiving an investigational device exemption (IDE). An IDE is often sought to support a PMA or Premarket Authorization. PMA is a review process that the FDA uses to evaluate if the Class III IDE is safe and effective.

When IDE’s Are Necessary For Medical Devices

Only in rare cases will a 510(k) require clinical data support to receive an IDE. Unless subject to an exception, investigational devices are required to receive an approved IDE before initiating a study. Those devices that have not been cleared for marketing must meet the following requirements for clinical evaluation:

  • The IRB (Institutional Review Board) must approve an investigational plan. The FDA must also approve the IDE if significant risk is involved.
  • All patients must provide informed consent.
  • The device must be clearly labeled as being for investigational use only.
  • The study must be monitored by authorized individuals.
  • The required reports and records must be collected.

Receiving an approved IDE allows a device to be shipped for use in investigations of the device without complying with the usual FD&C Act (Food, Drug, and Cosmetic Act) requirements. There is no need for sponsors to register their establishment, list the use of the device while it’s under investigation, or submit a Premarket Notification or PMA. These sponsors will also be exempt from regulation by the Quality System except for the design controls listed in (21 CFT 820.30).

Medical devices are categorized according to their risk factors.

  • Significant Risk Devices: These devices are those that have the potential to seriously impact the welfare, safety, or health of the patient. Life-support devices, implants, or those playing a significant role in treating, mitigating, curing, or diagnosing disease.
  • Non-Significant Risk Devices: These devices do not present a significant risk to the patients involved in the study. Ultrasonic dental scalers, contact lenses, and Foley catheters are some examples.

All devices to be used in clinical investigations must either receive an approved IDE or be exempt from these regulations. The regulations governing these approvals have recently undergone changes.

Updated Device Regulations and Studies From the FDA Code of Regulations

As the FDA’s Center for Devices and Radiological Health (CDRH) maintains responsibility for regulating clinical research firms for device studies or investigational device exemption, recent changes were announced on October 3, 2022, stating that clinical study centers can send an electronic copy (eCopy), electronic Submission Template, And Resource (eSTAR) premarket submissions. These can be submitted online through the (“CDRH Portal”). Since its development in 2021, the CDRH Portal has permitted open registration for a CDRH Portal account for delivering CDRH eCopy or eSTAR premarket submissions. As of October 1, 2023, all 510(k) non-exempted submissions require submission as electronic submissions using eSTAR.